Rennie Orange 500mg Chewable Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CALCIUM CARBONATE

Available from:

Bayer Limited 1st Floor The Grange Offices The Grange Brewery Road Stillorgan Co. Dublin, A94 H2K7 , Ireland

ATC code:

A02AC01

INN (International Name):

CALCIUM CARBONATE 500 mg

Pharmaceutical form:

CHEWABLE TABLET

Composition:

CALCIUM CARBONATE 500 mg

Prescription type:

OTC

Therapeutic area:

DRUGS FOR ACID RELATED DISORDERS

Authorization status:

Authorised

Authorization date:

2006-12-04

Patient Information leaflet

BCH22024
PACKAGE LEAFLET: INFORMATION FOR THE USER
RENNIE
® ORANGE_ _
_500MG CHEWABLE TABLETS _
Calcium carbonate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist
has told you.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any
possible side effects not listed in this leaflet. See section 4.
-
You must contact a doctor if you do not feel better or if you feel
worse after 7 days.
WHAT IS IN THIS LEAFLET
1. What Rennie
®
Orange is and what it is used for
2. What you need to know before you take Rennie
®
Orange
3. How to take Rennie
®
Orange
4. Possible side effects
5. How to store Rennie
®
Orange
6. Contents of the pack and other information
1. WHAT RENNIE
® ORANGE IS AND WHAT IS IT USED FOR?
RENNIE
® ORANGE
Chewable tablets get to work to provide fast-effective relief from
heartburn,
indigestion and acid reflux.
Each antacid tablet works to neutralise excess acid in the stomach.
You must talk to a doctor if you do not feel better or if you feel
worse after 7 days.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE RENNIE
® ORANGE
DO NOT TAKE RENNIE
® ORANGE:
•
If you have severe kidney disease or suffer from kidney stones.
•
If you have high calcium levels in the blood, kidneys or urine.
•
If you have low phosphate levels in the blood.
•
If you are allergic (hypersensitive) to calcium carbonate or any of
the ingredients of
this medicine
_(listed in Section 6). _
WARNINGS AND PRECAUTIONS:
Consult your doctor before taking Rennie
®
Orange if you have any kidney problems. This
product contains sucrose. If you have been told by your doctor that
you have an intolerance to
some sugars, contact your doctor before taking this medicinal product.
As with other antacid products, taking these tablets can ma

Summary of Product characteristics

BCH22024
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Rennie Orange 500mg Chewable Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Calcium Carbonate 500 mg (200mg elemental
calcium).
Excipients with known effect:
Each chewable tablet also contains ponceau 4R (E124) and 887.5 mg
sucrose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Chewable tablet
A square orange chewable tablet with rounded corners, bevelled edges
and concave faces.
4.
CLINICAL PARTICULARS
4.1
Therapeutic Indications
For the symptomatic relief of stomach upset due to hyperacidity and
heartburn, e.g. indigestion,
hyperacidity, flatulence, dyspepsia, biliousness and acid indigestion.
4.2
Posology and method of administration
Tablets to be taken orally, sucked or chewed, according to the
following dosage schedules:
Adults:
One or two tablets to be sucked or chewed as required, to a maximum of
eleven tablets a day and
should not be taken continuously for longer than 2 weeks.
Elderly
No special dosage regimen is required, but care should be taken to
observe the contraindications and
warnings.
Children
Not recommended for children under 12 years of age.
4.3
Contraindications
Rennie Orange should not be administered in the following cases:

Hypersensitivity to any of the ingredients of the product
BCH22024
2

Hypercalcaemia, hypercalciuria and/or conditions resulting in
hypercalcaemia e.g sarcoidosis

Nephrolithiasis due to calculi containing calcium deposits

Severe renal insufficiency

Hypophosphatemia
4.4
Special warnings and precautions for use
Rennie Orange
Prolonged use should be avoided. Do not exceed the stated dose and if
symptoms persist after
seven days, further medical advice should be sought.
Caution should generally be exercised in the case of patients with
impaired renal function. If
Rennie Orange is to be used in these patients, plasma calcium and
phosphate levels should be
regularly monitored.
As with other antacids, Rennie Orange tablets may ma